Invacare Corporation (NYSE: IVC) is trading down today after announcing that the FDA requested the company negotiate and agree to a consent decree of injunction relating to previously disclosed inspectional observations at its corporate and wheelchair manufacturing facilities in Elyria, Ohio. IVC reported that the FDA proposed a consent decree that would require suspension of certain operations at the facilities until they are determined by the FDA to be in compliance. As previously reported by IVC, it has also received a warning letter from the FDA following its inspection in the fall of 2010 of the company’s Sanford, Florida bed plant.
The FDA may not be the only regulator IVC is dealing with as it appears there is also an ongoing DOJ investigation dating back to 2006. IVC first disclosed in a January 2007 8-K that it had received a subpoena from the DOJ seeking documents relating to three long-standing and well-known promotional and rebate programs that it maintained. It was not until IVC’s 2007 10-K that the company disclosed that the subpoena was received in 2006. At that time, IVC also reported that it had not communicated with the DOJ concerning the matter in over a year. In the 2008 10-K, IVC gave investors no additional information on the matter, but replaced its statement that “it had not had any communication with the DOJ concerning the matter in over a year” with one stating “as of February 2009, the subpoena remains pending.” This disclosure remained similar in subsequent 10-Ks, including its last mention in the 2010 10-K, which indicated the subpoena remained pending as of February 2011.
Here are IVC's press releases.